Change Control Challenges - A Few Ways to Beat Them Up

Simply put, change control is the way that pharmaceutical, life science and technology companies (or any company for that matter) handle set-backs, \"unpredictables\" and upsets. Like people, companies have distinct ways of dealing with challenges and change. Some companies are calm......some have nervous breakdowns.

The question is this: How can your company avoid the change control breakdown?

The Change Control Debate

Some may say the key to good change control is a good quality control department. Others might say that interpersonal communication is the key.

Perhaps their arguments are convincing but they\'ve missed the big picture: change control software.

Change Control Software: Calm, Secure and Streamlined

Effective change control software (yep, technology wins again) is actually remaking change control processes and giving some companies the \"heads up\" on a calm and very streamlined change control process.

This article is designed to help companies see how the \"nervous breakdown\" change control process and the calm and collected change control process differ with the variance of only one factor: change control software.

Change Control Challenge Scenario #1: Communication

Communication is obviously central to change control processes. However, the way companies use communication in relation to their change control processes is not always commensurate with wisdom!

Company #1

Company #1 decides to handle communication the paper-based way. Company #1 wants to save money and to avoid the hassle of looking for effective change management software. Because their system is paper-based the company does save money (at least at first) but company #1\'s employees also spend more time connecting processes that are naturally disconnected (such as electronic spreadsheets, email clients and outdated hard copy SOPs). Their creation, routing and approval processes are manual (or hybrid) solutions and require that a lot of people waste a lot of time running around looking for the right people who are often inconveniently away from their desks. This results in a lot of outdated SOPs floating around on production floors, uncertainty regarding which document versions are the most recent, and frustrations with the \"ignorant\" lack of accountability on the part of employees who are supposed to be an essential part of the change control line up---not to mention a variety of headaches.

Poor Company #1. It\'s about to have a nervous breakdown.

Company #2

Company #2, on the other hand, is skipping gleefully through the meadows of change control bliss. Okay, so maybe they aren\'t skipping but at least they are confident that their change control process works. Why? Because their change control software system allows them to completely control their change control process online while simultaneously meeting all regulatory standards (FDA, ISO, EMEA and Sarbanes-Oxley compliance regulations). They can sit back and relax a bit because their change control process is connected. Their document management system is actually integrated with their change control system and with their CAPA, audit, customer complaint and training applications as well. Creation, routing and approval processes are all done electronically and/or automatically and are accompanied by version control features which act as assurances for companies who want only the latest (and greatest) version of a document to be available for revision. With their change control software, company #2\'s records are also archived for regulatory compliance.

Change Control Challenge Scenario #2: Subsequent Training
\r The training procedures associated with change control documentation and regulation make a difference in every department from research to production. Take a look at how two distinct companies manage their change control associated training.

Company #1

Company #1 decides that a paper based system is the way to go. After hours of legwork and manual routing and approvals, the change control process is \"finished\" (hopefully) and their documentation is delivered to the respective personnel who will implement it. Personnel members who receive the documentation however often fail to locate and destroy old versions of the new SOP (or related document) and will likely be uninformed as to 1) whether associated training is necessary for new SOP procedures, 2) when and where the training will occur and 3) whether any type of exam will be required for the training to be completed.

Company #2

Company #2 is NOT sweating the small stuff. They know their resultant SOPs will be automatically routed and approved by those persons specified during the set-up of their change control software. Applicable personnel will also 1) be aware of any outdated documents because those documents will either be electronically inaccessible or (for hard copies) be watermarked with appropriate dates, 2) will be updated regarding whether or not training is necessary, 3) will be apprised as to when and where training will occur, and 4) will be provided with electronic quizzes or exams if required for training procedures.

What are you waiting for?

It\'s no wonder that some companies are walking through change control wonderland. They have access to viable change control software! Start searching for a flexible change control software solution for your own company and save yourself a change control breakdown.

Marci Crane is a copywriter for MasterControl in Salt Lake City, UT. For more information in regards to change control software and implementation and training services, please feel free to contact a MasterControl representative.

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